Validation of Computer Systems for Quality and Software Embedded Medical Devices 2017

Overview:

Why should you attend:

• Understand Verification and Validation, differences and how they work together
• Develop a "Working Definition" of V&V, Qualification, and related terms
• Discuss recent regulatory expectations
• Software Verification & Validation requirements of the FDA and ISO.
• The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies
• Device and Manufacturing software requirements for V & V
• How to determine & demonstrate an appropriate V & V strategy
• How to determine & handle software for different Levels of Concern
• What V&V is required for 3rd Party software-custom and Off-the-shelf
• Impact of FDA, Mobile APPS, Cyber Security, and software standards such as IEC 62304
• What to look for during software vendor audits.
• V & V documentation and level of detail required for device submissions.
• How to document a "risk-based" rationale, and use it in a resource-constrained environment
• Determine key "milestones" and "tasks" in a project as well as discussing audience related projects for discussion points

Location: Baltimore, MD Date:  September 21st & 22th, 2017 and Time: 9:00 AM to 6:00 PM

Venue:   The DoubleTree Baltimore-BWI Airport   890 Elkridge Landing Road - Linthicum, MD 21090 USA

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 16, Regular Price: $1,495.00 

Register for 5 attendees   Price: $3,885.00      $6,475.00 You Save: $2,590.00 (40%)*

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900974SEMINAR?medtechiq-September-2017-SEO

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